in-depth-testing-of-computer-systems-regulated-by-fda

In-Depth Testing of Computer Systems Regulated by FDA

Live Webinar

  • 90 minutes

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to prepare your system validation documentation, including test protocols, scripts, and summary reports for an FDA audit of your company’s computer systems.

Join this session by expert speaker Carolyn Troiano, where she explain will how to construct solid functional requirements that can be used to create functional requirements that are unique and testable.

Session Highlights:

  • Determine the category of your system, based on GAMP 5 from ISPE

  • Determine the risks associated with the various ways your system may fail

  • Use the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted

  • Understand the FDA requirements for documentation of all testing activities

  • Understand how to write a test protocol for each phase of testing:

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ) [also referred to as User Acceptance Testing, or UAT]

  • Understand how to develop test scripts and acceptance criteria

  • Learn how to identify test discrepancies and distinguish the type: test script errors, tester errors, system errors

  • Learn how to document all testing and the summary reports

  • Learn about maintaining the system in a validated state, and keeping testing as a ‘living’ exercise that runs through the system life cycle

Why You Should Attend:

The Webinar will focus on testing as a key element of Computer System Validation (CSV). The level of testing must reflect both the potential risk associated with failure of the system to function properly. It must also be based on the systems’ classification in accordance with GAMP 5. You will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements.

Who Should Attend:

  • Information Technology Analysts

  • QC/QA Managers

  • QC/QA Analysts

  • Clinical Data Managers

  • Clinical Data Scientists

  • Analytical Chemists

  • Compliance Managers

  • Laboratory Managers

  • Automation Analysts

  • Manufacturing Managers

  • Manufacturing Supervisors

  • Supply Chain Specialists

  • Computer System Validation Specialists

  • GMP Training Specialists

  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit

  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

  • Auditors engaged in the internal inspection of labeling records and practices


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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